KEYNOTE: Steve Anderson, Chief Scientific Officer and Senior Vice President, Covance
Steven Anderson, PhD, is a Senior Vice President at Laboratory Corporation of America (LabCorp), and the Chief Scientific Officer for the Covance Drug Development business of LabCorp. He has been with the LabCorp organization for 28 years and has held a variety of positions including Director of Operations for ViroMed Laboratories, Director of Operations for Monogram Biosciences, Director of Operations for the Center for Molecular Biology and Pathology, Director of Operations for Integrated Oncology and Genetics, National Director of Research and Development, and Global Head of LabCorp Clinical Trials. Dr. Anderson is a member of a variety of professional societies including the American Association for Cancer Research, the American Society of Clinical Oncology and the Association for Molecular Pathology. Dr. Anderson’s research interests are in the development and applications for molecular diagnostics, including several examples of companion diagnostics and pharmacogenomic assays. He has authored more than 175 articles and abstracts published in such journals as Genetics, Proceedings of the National Academy of Sciences, Clinical Chemistry, the Journal of Infectious Disease, Human Pathology, American Journal of Obstetrics and Gynecology, Oncogene, the Journal of the National Cancer Institute, Clinical Cancer Research, Breast Cancer Research, BMC Cancer, the Journal of Molecular Diagnostics, Archives of Pathology and Laboratory Investigation and Expert Reviews in Molecular Diagnostics. He has a PhD in Genetics from Iowa State University, and was an American Cancer Society postdoctoral fellow at the Waksman Institute of Rutgers University.
KEYNOTE: Jeff Evelhoch, Vice President, Head of Translational Biomarkers, Merck & Co.
Dr. Jeffrey L. Evelhoch is vice president, Early Stage Development and head, Imaging at Merck Research Laboratories (MRL). In this role Jeff, provides leadership and coordination for the use of Preclinical and Clinical Imaging resources for all MRL franchises and functions. He ensures that imaging biomarkers are used optimally in the Target through IIB space and in late stage development to help advance Merck’s compounds through to registration. Dr. Evelhoch joined Merck in 2008, after four years at Amgen as executive director, Medical Sciences and head, Imaging Sciences. He also worked at Pfizer Global Research & Development and Pharmacia Corporation and was on the faculty of Wayne State University School of Medicine for 18 years, where he was a professor of Internal Medicine, Radiology and Cancer Biology. Dr. Evelhoch was named a Fellow of the International Society of Magnetic Resonance in Medicine (ISMRM) in 2003. He is actively involved in the joint efforts of professional organizations, industry groups and federal agencies to further the development and use of quantitative imaging, including The Biomarker Consortium, the Quantitative Imaging Biomarker Alliance and the ISMRM Ad Hoc Committee on Standards for Quantitative Magnetic Resonance. Dr. Evelhoch has a B.S. in chemistry from West Chester University and received his Ph.D. and M.S. in analytical chemistry from the University of California at Riverside. He was also a postdoctoral fellow at Washington University in St. Louis. Throughout his career, he has actively published and served on National Institutes of Health review committees; he is currently a member of the National Cancer Institute’s Experimental Therapeutics (NExT) Special Emphasis Panel.
KEYNOTE: John Danaher, Global President, Clinical Solutions, Elsevier
Dr. John Danaher, Elsevier’s President, Clinical Solutions, is a prominent life-long leader and expert in health and the business of health. At Elsevier, he heads the Clinical Solutions business focused on improving patient outcomes through optimizing provider performance and patient engagement. Clinical Solutions is focused on delivering industry leading products focused on improving care at every stage in the patient journey.
Previously he headed Elsevier’s Education business and led the transformation from a traditional publisher to an educational digital solutions provider focused on improving student outcomes. Prior to joining Elsevier, John was President of the Schools of Health Sciences and Nursing at Kaplan. He brings a great depth of experience in digital media in health care and education from his time at Kaplan, Discovery Communications, and as executive vice president of WebMD and part of the early management team. John has deep domain expertise and a successful track-record in managing health information businesses. His experience, in both government and the private sector, extends beyond the US and into global markets, including assignments and experience with Japan, Pakistan, the UK and Australia.
KEYNOTE: Jessica Atkinson, Vice President, BioPharma Business Development, Foundation Medicine
Ms. Atkinson joined Foundation Medicine in 2016 and currently serves as vice president, biopharma business development, and leads the biopharma business development organization. She has more than 14 years of business development and commercialization experience in the diagnostics and pharmaceutical industries, specializing in structuring complex partnerships, negotiating transactions, and partnering strategy. In her prior role at Foundation Medicine, Ms. Atkinson served as senior director, corporate and business development, leading companion diagnostics (CDx) business development efforts. Prior to joining Foundation Medicine, Ms. Atkinson served as a member of the business development team at Asuragen where she was responsible for developing and executing pharmaceutical partnerships and collaborations. Prior to Asuragen, she served in a leadership role within the commercial organization of Merck & Co. Ms. Atkinson earned her degree in Molecular Biology from The University of Texas at Austin.
Esther Abels, VP Regulatory Affairs, Clinical Affairs and Strategic Business Development, PathAI
Esther Abelsis is VP of Regulatory & Clinical Affairs and Strategic Business Development at PathAI. She graduated in Biomedical Health Science, toxicology. Experienced in clinical validation studies used for regulatory purposes in USA, Europe and Asia. Has a background in bridging R&D, Proof of Concept and socio economics studies. Was Clinical Research Scientist and Global Clinical Trial Manager for pivotal regulatory studies in both pharma and biotech. Worked and lived in NL as well as USA prior to relocating to Boston USA to join PathAI in 2018. She played a crucial role in the Digital Pathology Association (DPA) Regulatory and standards Taskforce and FDA collaborations. The successful outcome was that WSI for primary diagnosis was recommended to become a class II instead of class III device in the United States. She also played an integral role and led the entire regulatory, clinical and medical affairs trajectory within Philips Digital Pathology Solutions (DPS) for Whole Slide Imaging devices to be marketed for “HER-2” as well as for “Primary Diagnosis” in as well US as in EU, CAN, Singapore and part of APAC. Esther is currently Chair of the DPA Regulatory and Standards Taskforce where she is spearheading regulatory and standards clarifications for interoperability and computational pathology as well as working on reimbursement in DP.
Pat Adams, Senior Genomic Liaison, Regional Trainer, Genomic Health
For the past 17 years, I have worked in molecular diagnostics within oncology. My experience includes; hereditary cancer testing, genomic assays for determining risk of recurrence and chemotherapy benefit, circulating tumor cell assays for treatment decisions in prostate cancer as well as pan cancer comprehensive genomic testing in both tissue and blood. I believe that to bring the full value of precision medicine to patients, all aspects of the testing process must be optimized. This includes the identification of patients who would benefit from testing, ordering appropriate tests at the earliest opportunity, efficient processing of prior authorization requirements, rapid send out of specimens, reflex testing established where appropriate and results received by provider without delay. Most recently, my focus has been on working with pathologists on optimizing the retrieval and processing of tissue specimens for NGS. I believe that in striving to change medical practice, it is incumbent on industry to build effective collaborations with all parties involved in testing if patients are to receive timely information to help them with treatment decisions. For the past 4 years, I have also been involved in mentoring students interested in careers in the Life Sciences at the University of Connecticut. One of the students I mentored is now a colleague. I believe that by supporting students with exceptional skills and commitments, our industry with advance to its full potential.
Neeraj Adya, Director Pharmacodiagnostics, Bristol-Myers Squibb
Neeraj Adya has over 19 years of expertise in the In Vitro Diagnostics (IVD) medical device industry, specifically in developing and supporting diagnostic assays. For the last ~3.5 years he has been a Pharmacodiagnostics (PDx) Lead at BMS, enabling development of Companion/Complementary diagnostics in various therapeutic areas, including Oncology, Fibrosis, and Cardiovascular. In this role, he serves as a SME for medical device, provides PDx leadership for complementary and companion diagnostic activities by setting PDx strategy for various assets followed by managing a PDx team to execute on the strategy by facilitating delivery of all diagnostics by working with external diagnostic business partners. Prior to BMS, he was at Abbott Laboratories for over 15 years where he led cross-functional teams to develop blood screening diagnostics products for infectious diseases as well as development of new molecular companion diagnostic assays (CDx) with multiple Pharma partners in Oncology across multiple indications. Neeraj received his PhD in Molecular Biology from Case Western Reserve University at Cleveland, Ohio. Subsequently, he was a Postdoctoral Research Fellow at the National Human Genome Research Institute in NIH.
Andrew Aijian, Principal, DeciBio
Andrew Aijian is a Principal at DeciBio Consulting, where he leads market landscape, product development, and strategy engagements for a wide variety of stakeholders in the biotechnology and life sciences industries. Andrew’s areas of interest and expertise include oncology biomarkers and diagnostics, -omics technologies, pharmaceutical services, and business intelligence data aggregation and visualization. At DeciBio, Andrew has led CDx-related market evaluation and strategy engagements for stakeholders across the CDx landscape, include diagnostic manufacturers, pharmaceutical services providers, translational research tools companies, and pharmaceutical manufacturers. Andrew has also served as author and editor for DeciBio’s companion diagnostics and oncology diagnostics market research reports, and developed DeciBio’s Immuno-Oncology Biomarker Analysis Platform and associated database of I/O clinical trial biomarkers. Andrew earned his Ph.D. in Biomedical Engineering from UCLA, focusing on the development of microfluidic research tools for biomedical applications. He obtained his B.S. in Chemical and Biomolecular Engineering from the University of Notre Dame.
Jeff Allard, Founder and President, Lakeside Life Science
Jeff earned his Ph.D from Dartmouth College, in Biochemistry. Since obtaining his Doctorate, Dr. Allard has brought six “new to the world” diagnostic tests through FDA, with >30 FDA Clearances and Approvals. He has launched sixteen new products. He has authored over 100 scientific papers and abstracts, and invented, developed, and obtained FDA clearance for the first complexed PSA assay.
Paul Allard, COO, Lakeside Life Science
Paul Allard is a Registered Nurse and Cofounder of Lakeside Life Science. Paul saw the need to bring patients back to the foreground of clinical research. He has a proven history of clinical site management as well as a vision to bring academic centers and community centers together to further medical research. Paul manages all day-to-day operations of the company.
Andy Beck, CEO, PathAI
Andy earned his MD from Brown Medical School and completed residency and fellowship training in Anatomic Pathology and Molecular Genetic Pathology from Stanford University. He completed a PhD in Biomedical Informatics from Stanford University, where he developed one of the first machine-learning based systems for cancer pathology. He is board certified by the American Board of Pathology in Anatomic Pathology and Molecular Genetic Pathology. Prior to co-founding PathAI, he was on the faculty of Harvard Medical School in the Department of Pathology at Beth Israel Deaconess Medical Center. He has published over 110 papers in the fields of cancer biology, cancer pathology, and biomedical informatics.
Flora Berisha, Director of Companion Diagnostics, Daiichi Sankyo
Flora Berisha is a Director of Companion Diagnostics, at Daiichi Sankyo Pharma. Flora received her BS in Biochemistry and Master Degree in Biology from City University of New York. She currently lead CDx development for multiple projects in the oncology portfolio. Prior to Daiichi Sankyo, Flora was at Kyowa Hakko Kirin Pharma as a Senior Manager. At KHK she focused on strategic biomarker selection, development and translation into CDx assays. She was the CDx lead on representing the strategies to external partners and regulatory agencies. Prior to KHK, Flora was at BristolMyers Squibb where she progressed through the ranks gaining valuable experience in GLP and clinical Bioanalysis, biomarker and CDx assay development from design control through commercialization. In addition to Flora’s industry experience, she is currently an Adjunct Professor in the Department of Biology at CUNY (City university of New York) where she teaches anatomyphysiology and biology over a decade.
Nic Dracopoli, Chief Scientific Officer, Delfi Diagnostics
Nicholas (Nic) Dracopoli, Ph.D. is Chief Scientific Officer at Delfi Diagnostics, a seed stage cancer diagnostics company based in Baltimore, MD. Previously he led oncology translational science teams at Bristol-Myers Squibb and Janssen. Prior to joining the pharmaceutical industry, he spent several years in the biotechnology industry at Sequana Therapeutics. Nic obtained his bachelor’s degree and doctorate from the University of London and completed post-doctoral fellowships at the Memorial Sloan-Kettering Cancer Center in New York City, NY and the Massachusetts Institute of Technology (MIT) in Cambridge, MA. Subsequently, he served as an Assistant Director at the Whitehead/MIT Genome Center and as a Section Chief at the National Center for Human Genome Research at the National Institutes of Health. Nic has authored more than 70 scientific publications and has extensive experience in the fields of genomics, molecular biology and cancer research.
Colin Enderlein, Associate, DeciBio
Colin Enderlein has been active in precision medicine innovation and CDx commercialization at multiple phases of the R&D value chain in both the public and private sectors. Following the completion of his graduate work at The Karolinska Institute, Colin worked with the business development team at Seattle Children’s Research Institute to establish industry partnerships with a focus on curing childhood diseases. From here, Colin joined the business development team at NanoString, where activities focused on CDx partnering and execution, and technology due diligence. He is currently an Associate with DeciBio Consulting, where he specializes in research related to I/O therapies and their associated biomarkers, spanning both the pharmaceutical and genomic tools markets.
Anka Ehrhardt, Science Director, CHDI Management
Dr. Ehrhardt is a biophysicist, holding a Ph.D. in physiology. As a leader in technology-based biological research, she is known for driving collaboration and pragmatic innovation. Throughout her career, both in academia and the pharmaceutical industry, Dr. Ehrhardt has developed and implemented innovative assays to drive programs and achieve results.
Leeona Galligan, VP UK Operations, Almac
Dr Galligan (PhD, FRCPath) has worked for over 15 years in the field of translational molecular oncology and holds the post of Head of Laboratory Operations at Almac Diagnostics where she has overall responsibility for all laboratory based technologies and services supporting Almac Diagnostics’ biomarker discovery, development and delivery.
Mark Girardi, Vice President, Boston Healthcare Associates
Mark Girardi has over 30 years of experience in life sciences, in vitro diagnostics, and medical devices commercialization and reimbursement. He has had roles in product management, sales and marketing, and most recently in strategy consulting. Mr. Girardi joins Boston Healthcare from GfK Health, a global consultancy and market research firm, where he was Senior Vice President responsible for the MedTech consulting practice. Prior to joining GfK, Mr. Girardi spent five years at Predictive Biosciences as VP of Sales and Marketing. He also served as Senior Director of Marketing at Z-Tech Medical where he was responsible for commercialization of the company’s breast cancer screening devices. As a Director of Marketing at Cytyc Corporation (now Hologic), he managed the worldwide launch of the Thin Prep Imaging System. Mark has also held senior marketing positions at Genzyme Genetics and Millipore. Mr. Girardi received his BS in Chemistry from Merrimack College and an MS in Analytical Chemistry from the University of New Hampshire.
Matt Kuruc, Vice President of Business Development, Biotech Support Group
Matt Kuruc is a serial entrepreneur with a special focus on functional proteomic biomarkers and technologies. As Vice President of Business Development for Biotech Support Group, he enlists collaborators for a new commercialization plan featuring: a) variant sub-populations (also known as proteoforms) of proteolytic regulating proteins called Serpins, with functional protein reporting features that clearly distinguish differences between cancer patients and normal/healthy individuals, and b) a measurable cancer profile obtained from blood, that can be modeled with categorical biomarker proteins taken from inflammation, blood coagulation, and complement.
Kamala Maddali, Senior Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics, Cancer Genetics
Dr. Kamala K Maddali is currently Vice President, Biopharma Collaborations, Market Development and Companion Diagnostics at Cancer Genetics Inc, Rutherford, NJ. Cancer Genetics, Inc. (CGI) is a leader in the field of personalized medicine, offering diagnostic products and services that enable precision medicine in the field of oncology. Dr. Maddali holds a DVM Ph.D., in Pharmacology from University of Missouri-Columbia and a DVM Veterinary Medicine from Acharya N.G. Ranga Agricultural University in India. Dr. Maddali brings over 10 years of extensive experience of global P&L scientific and commercial management of clinical biomarker and companion diagnostics (CDx) services covering personalized medicine strategy. She has promoted the proper utilization of biomarkers, personalized medicine and diagnostics in drug development and patient management to bridge the gap between drug and diagnostic industries. She was Global Director Scientific Development -Biomarkers & Companion Diagnostics for Q2 Solutions (A Quintiles & Quest Diagnostics joint venture). She brings a lot of strategic values from her previous roles at Quest Diagnostics, Quintiles and Merck Schering Plough in the arena of biomarkers and companion diagnostics.
Matt Marton, Director, Companion Diagnostics & Genomics, Merck & Co.
Matthew Marton is Director of Clinical Genomics in Merck & Co.’s Molecular Biomarkers & Diagnostics department, where his team has deployed predictive biomarkers as patient enrichment assays on multiple technology platforms in over a dozen Merck clinical studies. His current work focuses on the CoDx strategy of novel genomic assays as molecular diagnostics, and he is a contributor to several CLSI documents involving molecular diagnostic testing in oncology. Prior work at Merck focused on technology/method development and biomarker discovery, with an emphasis on quality control of molecular profiling assays. Earlier in his career, Dr. Marton worked with Drs. Stephen Friend and Lee Hartwell at the Seattle Project, a drug discovery think tank, which led to the founding of Rosetta Inpharmatics, a biotechnology company that was acquired by Merck in 2001. At Rosetta and subsequently at Merck, he led scientific efforts to create a GLP-like high throughput functional genomics laboratory. Dr. Marton completed post-doctoral training at the NIH and holds a PhD from Princeton University and a Certificate in Biomedical Regulatory Affairs from the University of Washington.
Hannah Mamuszka, CEO, Alva10
Hannah Mamuszka is the Founder and CEO of Alva10, a consultancy that focuses on bringing diagnostics to the forefront of Precision Medicine by partnering with payers and diagnostic developers to create a new value-based healthcare model. Ms Mamuszka has spent 20 years in biotech and diagnostics, with extensive experience in both drug and diagnostic development, validation, and commercialization. Prior to founding Alva10, Ms Mamuszka was VP of Business Development at Exosome Diagnostics, where she led some of the earliest deals in the liquid biopsy diagnostic space. Earlier in her career, she was Global Director for Pharma Services at Exiqon A/S (now QIAGEN), and worked as a scientist on the NDA for Bortezmib (Velcade) at Millennium Pharmaceuticals (now Takeda). She regularly speaks on issues regarding advancement of technology in healthcare, is a Board of Directors for two diagnostic companies and writes a column on the value of diagnostics for the Journal of Precision Medicine.
Rob Monroe, Chief Medical Officer, Bio-Techne
Dr. Rob Monroe, Chief Medical Officer of Bio-Techne and Advanced Cell Diagnostics, leads the company’s efforts to develop diagnostic and CDx applications with the RNAscope platform. In this role, Dr. Monroe works with pathologists and researchers to identify unmet clinical needs in biomarker testing and subsequently oversees development of RNAscope-based tests for these diagnostic applications. Dr. Monroe also serves as the clinical lead in ACD’s CDx partnerships with Leica Biosystems and multiple biopharma companies for the development of CDx assays using RNAscope technology. Prior to ACD, Dr. Monroe served as Medical Director and VP Laboratory Operations for Veracyte, a diagnostics company focused on molecular cytology. Prior to Veracyte, Dr. Monroe served as Chief Medical Officer of BioImagene (acquired by Roche in 2010), a leading provider of imaging solutions for anatomic pathology, where he headed development of software applications for pathologists, including multiple FDA-cleared algorithms for immunohistochemistry. Dr. Monroe holds an MD/PhD from Harvard and is board-certified in cytopathology, anatomic pathology, and clinical pathology.
Jose Moreno, Clinical Associate Professor of Urology, Thomas Jefferson University
Jose G Moreno, M.D. received his bachelor of science degree in biology from Loyola Marymount University in Los Angeles, California in 1983, and his medical degree from the University of Southern California School of Medicine in 1987. He served his general surgery residency at the University of California at Irvine, and a surgical oncology fellowship at the City of Hope in Duarte, California. He completed his urology residency at Thomas Jefferson University Hospital in Philadelphia. Dr. Moreno has worked on circulating prostate cancer cell research since 1991, and he has been awarded 4 US patents. He has been a principal investigator in a number biomarker clinical trials. He is a Clinical Associate Professor of Urology at Thomas Jefferson University Hospital, and he has been in his current private practice since 1995. He has served as President of the medical staff at Pottstown Memorial Medical Center, and President of the Urology Association of Pennsylvania. He is certified in DaVinci robotic surgery and has extensive experience with female pelvic reconstruction procedures.
Oscar Puig, Translational Medicine Team Lead, Oncology, Bristol-Myers Squibb
Oscar Puig was the Chief Scientific Officer at Phosphorus, a genetic diagnostic company founded in 2016 that develops diagnostics for complex genetic diseases and software for clinical data management and analysis. We currently commercialize three genetic panels (Reproductive Health, Cardiology, and Oncology). Prior to that, he was a Biomarker Leader in Oncology at the Roche Innovation Center in New York. He earned his Ph.D. at the University of Valencia, Spain, and carried out postdoctoral research at the European Molecular Biology Laboratory, in Heidelberg, Germany, and in the lab of Bob Tjian, at UC Berkeley, CA. Before joining Roche in 2012, he worked at Merck and at the University of Helsinki, where he is a docent. Dr Puig has over 40 publications in peer-reviewed journals.
Julie Ramage, National Accounts Director, Diagnostics, Oncology, Pfizer
With over 23 years of experience in the lab industry, working for many large commercial labs in Management of Sales related roles, Julie joined Pfizer Oncology five years ago to provide subject matter expertise to their growing portfolio of therapies with companion diagnostic activities. With expansive background in pathology, technologies, platforms, reimbursement and regulatory matters, Julie has also become one of Pfizer Oncology’s primary experts in data aggregation, purchase, and evaluation within the business unit in regards to biomarkers. Julie also serves on the Board of Directors for the California Clinical Lab Association as their previous president and now as the Secretary of the board. She is involved in many organizations such as Precision Medicine Coalition, and patient advocacy groups.
Aaron Schetter, FDA
Aaron Schetter, PhD MPH, is scientific reviewer in the Division of Molecular Genetics and Pathology/Office of in vitro Diagnostics/CDRH/FDA where he performs premarket review of molecular- and immunohistochemistry-based in vitro diagnostics for a variety of oncology indications. He earned his PhD in molecular biology and Genetics from Cornell University and MPH focusing on epidemiology and biostatistics from University of California at Berkeley. Prior joining the FDA in 2014, Aaron spent 10 years at the National Cancer Institute where he focused on molecular profiling of various tumor types to identify potential biomarkers and therapeutic targets. His research has led to (co)authorship for over 50 manuscripts in peer-reviewed journals and 9 US patents.